Efficacy and Safety of Leuprolide Acetate 22.5 mg Depot in Treatment of Prostate Cancer
Public ClinicalTrials.gov record NCT01415960. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy and Safety of a New Leuprolide Acetate 22.5 mg Depot Formulation in the Treatment of Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Some patients with prostate cancer benefit from androgen deprivation therapy which reduces levels of testosterone. Leuprolide is a synthetic Luteinizing hormone releasing hormone (LHRH) analogue which upon administration can decrease testosterone levels to ≤0.5 ng/mL. Leuprolide Acetate 22.5 mg Depot is a microencapsulated formulation of leuprolide which is released slowly over time and effectively reduces testosterone levels in many patients to ≤0.5 ng/mL for up to three months. In this study Leuprolide acetate 22.5 mg Depot will be administered by intramuscular injection twice over a period of 6 months. The proportion of patients with testosterone ≤0.5 ng/mL evaluated over a period of 168 days.
Study identification
- NCT ID
- NCT01415960
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 163 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2011 (Type not available)
- Primary completion
- May 2013 (Actual)
- Completion
- Nov 2013 (Actual)
- Last update posted
- Mar 3, 2017
2011 – 2013
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Genesis Research | San Diego | California | 92123 | — |
| Atlantic Urological Associates | Daytona Beach | Florida | 32114 | — |
| Urology Health Team | Ocala | Florida | 34474 | — |
| Winter Park Urology Associates, PA | Orlando | Florida | 32803 | — |
| Coastal Medical Center | Sarasota | Florida | 34237 | — |
| North Idaho Urology | Coeur d'Alene | Idaho | 83814 | — |
| Idaho Urologic Institute | Meridian | Idaho | 83642 | — |
| First Urology | Jeffersonville | Indiana | 47130 | — |
| Mid Atlantic Clinical Research | Greenbelt | Maryland | 20770 | — |
| Premier Urology Associates, LLC | Lawrenceville | New Jersey | 08648 | — |
| The Urological Institute of Northeastern New York | Albany | New York | 12208 | — |
| Brooklyn Urology Research Group | Brooklyn | New York | 11215 | — |
| Manhattan Medical Research | New York | New York | 10016 | — |
| The Premier Medical Group of the Hudson Valley, PC | Poughkeepsie | New York | 12601 | — |
| Staten Island Urological Research, PC | Staten Island | New York | 10304 | — |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | — |
| PMG Research of Winston Salem | Winston-Salem | North Carolina | 27103 | — |
| Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Urology Health Specialists, LLC | Bryn Mawr | Pennsylvania | 19010 | — |
| Greenville Health System | Greer | South Carolina | 29650 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Urology Associates, PC | Nashville | Tennessee | 37209 | — |
| Urology San Antonio Research, PA | San Antonio | Texas | 78229 | — |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | — |
| Seattle Urology Research Center | Burien | Washington | 98166 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01415960, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 3, 2017 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01415960 live on ClinicalTrials.gov.